NCT04569032 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Participants with \<1% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of each 21-day cycle, Cyclophosphamide 750 milligram per square meter (mg/m\^2) IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.
- id
- FG000
- title
- CD30 <1% [Local Laboratory Assessment]
- description
- Participants with 1% to \<10% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle, Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.
- id
- FG001
- title
- CD30 1% to <10% [Local Laboratory Assessment]
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 10
- group Id
- FG001
- num Subjects
- 13
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 0
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 22
- group Id
- FG001
- num Subjects
- 34
- type
- In long term follow up
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 34
- group Id
- FG001
- num Subjects
- 48
- comment
- Based on Local Laboratory Assessment
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 34
- group Id
- FG001
- num Subjects
- 48
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- Results reported are based on the primary completion date (PCD) of the study; data for only those secondary outcome measures are reported for which analyses were complete at PCD. Remaining outcome measures would be reported upon completion of their analyses at study completion.
- recruitment Details
- Participants who had newly diagnosed non-systemic anaplastic large cell lymphoma (sALCL) peripheral T-cell lymphoma (PTCL) with \< 10% CD30 expression, were enrolled to receive A+CHP treatment (brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone). Enrollment was based on CD30 expression per local laboratory assessment. Analysis of efficacy outcome measures was based on CD30 expression per central laboratory assessment.
Complete source fields
- groups
- description
- Participants with \<1% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of each 21-day cycle, Cyclophosphamide 750 milligram per square meter (mg/m\^2) IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.
- id
- FG000
- title
- CD30 <1% [Local Laboratory Assessment]
- description
- Participants with 1% to \<10% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle, Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.
- id
- FG001
- title
- CD30 1% to <10% [Local Laboratory Assessment]
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 10
- group Id
- FG001
- num Subjects
- 13
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 0
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 22
- group Id
- FG001
- num Subjects
- 34
- type
- In long term follow up
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 34
- group Id
- FG001
- num Subjects
- 48
- comment
- Based on Local Laboratory Assessment
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 34
- group Id
- FG001
- num Subjects
- 48
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- Results reported are based on the primary completion date (PCD) of the study; data for only those secondary outcome measures are reported for which analyses were complete at PCD. Remaining outcome measures would be reported upon completion of their analyses at study completion.
- recruitment Details
- Participants who had newly diagnosed non-systemic anaplastic large cell lymphoma (sALCL) peripheral T-cell lymphoma (PTCL) with \< 10% CD30 expression, were enrolled to receive A+CHP treatment (brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone). Enrollment was based on CD30 expression per local laboratory assessment. Analysis of efficacy outcome measures was based on CD30 expression per central laboratory assessment.
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Preserved source evidence · Not medical advice
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